Issue 124

Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

Here’s what going on this week in FDA-regulated and pharma-related digital health:

• Last week in Issue 123, I mentioned Pear Therapeutics’ VBC with MassHealth, the Medicaid program in Massachusetts, and I linked to a tweet from the former Chief Medical Officer of Medicaid that suggested Pear didn’t have Medicaid beneficiaries represented in its research studies. Turns out some of Pear’s studies did include people on Medicaid, which led to this exchange between a former Pear exec and the former Medicaid CMO on Twitter.
• Luminopia announced it had secured FDA approval this week for its prescription digital therapeutic, Luminopia One, for amblyopia. Here’s the IFU: “Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.”
• The FDA just posted a draft guidance document called “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
• The German government added its twenty-fourth reimbursed digital therapeutic to its national formulary: HelloBetter, which is an online course for stress and burnout. The program runs about three months and will cost the government about $700 per Rx. More in the E&O DiGA tracker here.
• The Consumer Technology Association, which puts on the big CES conference each year, announced that “the biggest challenge in the digital therapeutics industry is the wide variety of terms used to define it.” So it convened a new group to create yet another definition, which you can find a link to here. I first mentioned this in August 2020 (Issue 067) and noted back then that I hoped the CTA worked with the DTA on this initiative. Turns out they did join up with the DTA eventually, which is probably why the CTA definition is pretty close to DTA’s.
• Speaking of the Digital Therapeutics Alliance: The DTA joined a handful of others in submitting final comments to CMS on its proposed decision to walk away from the proposed MCIT rule: “DTA does not support the decision to repeal the MCIT/R&N final rule. In anticipation that this proposed repeal is either temporary, or that during this time CMS continues to weigh proposals, we urge CMS to consider that in its current form, MCIT/R&N is not inclusive of all innovative products such as digital medicine, and particular, Digital Therapeutics. CMS should examine all available statutory authorities to allow coverage of digital medical innovations that are proving to better suit the needs of Medicare beneficiaries through growing evidence.”
• Click Therapeutics announced a $52 million Series B co-led by new investors H.I.G. BioHealth and Accelmed along with other new backers like Health Catalyst Capital and Revelation Partners.
• 23andMe announced plans to acquire virtual care provider Lemonaid Health for $400 million in a mix of cash ($100 million) and stock ($300 million). In its (Richard Branson-backed) SPAC presentation a few months ago (Issue 087), 23andMe said it would move into virtual care. So, this is not a wholly unexpected move from the consumer genetics company.
• Babylon Health, which SPAC’d itself onto the public markets today, is looking to hire a regulatory expert with SaMD experience. Currently, Babylon has no FDA-authorized SaMD so this could indicate a future offering from the chatbot-based care provider.
• One more thing… Just noticed this (new-ish, I think?) marketing line from Akili for EndeavorRx: “The medicine made from pixels.”

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BehaVR expands Sunovion deal beyond SAV-985

This week BehaVR and Japanese pharma company Sumitomo Dainippon’s subsidiary Sunovion expanded on their partnership, which started up in mid-2020 when they announced plans to bring to market a VR-powered general wellness offering targeting social anxiety disorder. Now the companies have “signed definitive agreements to develop and commercialize both prescription digital therapeutics and general wellness products for treatment of Social Anxiety Disorder (SAD), Generalized Anxiety Disorder (GAD), and Major Depressive Disorder (MDD).”

Here’s how the payment will work:

First up: SAV‐985 VR for social anxiety disorder

Sumitomo and BehaVR are in the process of setting up a feasibility test for their VR-powered social anxiety DTx (code-named SAV-985 for now). The DTx uses cognitive behavioral therapy, exposure therapy, and mindfulness as part of its virtual reality therapeutic. Here’s how Sumitomo described the current state of the project in a recent investor update:

After the consumer launch in late 2022, the companies plan to pursue commercializing it as a prescription digital therapeutic. I assume the other two targets (GAD, MDD) will skip over direct-to-consumer launches and stick to a prescription digital therapeutic model.

Trial updates: Amgen shuts down Biobeat HF study; Swing Tx; Pfizer

Here’s E&O’s weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.

Amgen terminates its blood pressure-sensing wearable-powered heart failure study

Amgen shut down its heart failure study:

Amgen cited enrollment challenges “exacerbated by Covid–19” as the reason for the termination. Here’s the intervention group description:

Swing Therapeutics completes one DTx fibromyalgia study, tweaks exclusion critera for another

Swing Therapeutics’s 67-person fibromyalgia study, called SMART-FM, kicked off last October and finished up in August. The study included two digital ACT (Digital Acceptance and Commitment Therapy) interventions, but it’s not clear from the study’s posting how they differed. A third group received a digital symptom tracker instead of ACT. Here’s the study’s brief description:

Meanwhile, Swing’s bigger study, REACT-FC, which aims to recruit 500 participants, tweaked its exclusion criteria. Previously, the company was looking to exclude people with lupus, inflammatory arthritis, failed back surgery syndrome, or migraines. Those were removed and now the exclusion criteria rule out people with any type of dementia or a current diagnosis of cancer. Here’s the study’s brief:

Pfizer’s sensor study to evaluate physical performance in oncology patients

Pfizer’s study comparing digital measures (from seven digital devices) and patient-reported assessments for oncology assessments more or less wrapped up. It expects to be fully completed by next August:

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